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Drug Recalls

Last updated

Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.

3 Class I (most serious) drug recalls reported in the last 30 days.

3,250 recalls

  • Class II Ongoing

    Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06082016C (11/09/2016), 07222016B (01/18/2017), 09012016A (02/28/2017), 06012016C (11/09/2016), 08042016E (01/31/2017), 10032016A (04/01/2017).
    Distribution
    Nationwide
    Quantity
    882 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0304-2017
  • Class II Ongoing

    Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07132016D (01/09/2017), 11072016B (05/06/2017).
    Distribution
    Nationwide
    Quantity
    152 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0303-2017
  • Class II Ongoing

    Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06272016A (12/24/2016), 08242016A (02/20/2017), 09212016B (03/20/2017), 07252016A (01/21/2017), 08112016B (02/07/2017), 10252016L (02/28/2017).
    Distribution
    Nationwide
    Quantity
    1,244 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0302-2017
  • Class II Ongoing

    Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07262016A (01/22/2017), 07132016C (01/09/2017), 08302016A (02/26/2017), 08042016D (01/31/2017), 11012016K (04/30/2017), 09202016D (03/19/2017), 10032016B (04/01/2017), 08102016A (02/06/2017), 09282016D (03/27/2017), 09222016E (03/21/2017), 09152016A (02/28/2017), 09062016B (02/28/2017), 10252016C (02/28/2017), 10042016E (04/02/2017).
    Distribution
    Nationwide
    Quantity
    1,544 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0301-2017
  • Class II Ongoing

    Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05252016A (11/21/2016), 06272016B (12/24/2016), 07262016D (01/22/2017), 07182016H (01/14/2017), 07182016G (01/14/2017), 08252016C (02/21/2017), 08222016B (02/18/2017), 08102016A (02/06/2017), 09282016D (03/27/2017), 09222016E (03/21/2017), 09152016A (02/28/2017), 09062016B (02/28/2017), 10252016C (02/28/2017), 10042016E (04/02/2017).
    Distribution
    Nationwide
    Quantity
    7,168 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0300-2017
  • Class II Ongoing

    Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016D (11/19/2016), 06162016A (12/13/2016), 06132016A (12/10/2016), 07282016I (01/24/2017), 08172016D (02/13/2017), 08042016C (01/31/2017), 09222016F (03/21/2017), 09062016A (02/28/2017), 10272016B (02/28/2017), 10252016D (02/28/2017), 08252016B (02/21/2017), 11022016C (05/01/2017).
    Distribution
    Nationwide
    Quantity
    2,818 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0299-2017
  • Class II Ongoing

    Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05122016B (11/18/2016), 08012016C (01/28/2017), 09262016D (03/25/2017).
    Distribution
    Nationwide
    Quantity
    400 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0298-2017
  • Class II Ongoing

    Testosterone Cypionate in Sesame, 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Testosterone Cypionate in Sesame, 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07152016A (01/11/2017), 08182016A (02/14/2017), 09282016J (03/27/2017).
    Distribution
    Nationwide
    Quantity
    166 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0297-2017
  • Class II Ongoing

    Taurine 50 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Taurine 50 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06282016C (12/25/2016), 10242016A (10/27/2016), 10212016A (10/24/2016).
    Distribution
    Nationwide
    Quantity
    90 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0296-2017
  • Class II Ongoing

    Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1 mg/Pyridoxine HCL 2.2mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50mg/Methylcobalamin 1 mg/Pyridoxine HCL 2.2mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06292016A (12/26/2016), 08102016C (01/31/2017), 10262016C (02/28/2017).
    Distribution
    Nationwide
    Quantity
    127 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0295-2017
  • Class II Ongoing

    Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Sermorelin GT (Sermorelin Acetate 15 mg/GHRP-2 5.4 mg/Theanine (L) 75 mg). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06152016B (12/12/2016), 07252016C (01/21/2017), 08262016C (02/22/2017), 10192016A (02/28/2017), 10242016B (02/28/2017).
    Distribution
    Nationwide
    Quantity
    920 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0294-2017
  • Class II Ongoing

    Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05252016B (11/21/2016), 06232016B (12/20/2016), 07152016B (01/11/2017), 08262016D (01/30/2017), 08152016A (01/30/2017), 08022016C (01/29/2017), 09282016C (03/27/2017), 10192016C (04/17/2016), 10252016B (04/23/2017).
    Distribution
    Nationwide
    Quantity
    2116 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0293-2017
  • Class II Ongoing

    Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05252016C (11/21/2016), 07252016B (01/21/2017), 09192016B (03/18/2016).
    Distribution
    Nationwide
    Quantity
    441 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0292-2017
  • Class II Ongoing

    Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06152016C (12/12/2016), 10242016C (04/22/2017).
    Distribution
    Nationwide
    Quantity
    188 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0291-2017
  • Class II Ongoing

    Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 10192016A (04/17/2017).
    Distribution
    Nationwide
    Quantity
    7 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0290-2017
  • Class II Ongoing

    Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 08152016B (02/11/2017).
    Distribution
    Nationwide
    Quantity
    91 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0289-2017
  • Class II Ongoing

    Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 08022016B (01/29/2017).
    Distribution
    Nationwide
    Quantity
    54 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0288-2017
  • Class II Ongoing

    Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06062016D (12/03/2016), 08022016A (01/29/2017).
    Distribution
    Nationwide
    Quantity
    260 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0287-2017
  • Class II Ongoing

    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07252016E (09/04/2016), 09142016A (09/29/2016), 07192016E (09/01/2016), 07052016B (08/04/2016).
    Distribution
    Nationwide
    Quantity
    17 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0286-2017
  • Class II Ongoing

    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07222016B (09/01/2016).
    Distribution
    Nationwide
    Quantity
    5 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0285-2017
  • Class II Ongoing

    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 08102016F (09/18/2016).
    Distribution
    Nationwide
    Quantity
    5 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0284-2017
  • Class II Ongoing

    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/19mg/190mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06072016F (07/17/2016), 08112016C (09/18/2016).
    Distribution
    Nationwide
    Quantity
    10 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0283-2017
  • Class II Ongoing

    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 10262016H (12/09/2016), 11032016C (12/09/2016).
    Distribution
    Nationwide
    Quantity
    10 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0282-2017
  • Class II Ongoing

    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06162016B (07/17/2016).
    Distribution
    Nationwide
    Quantity
    2 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0281-2017
  • Class II Ongoing

    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy

    Reason: Lack of Assurance of Sterility

    Tri-Coast Pharmacy

    Lots, distribution and details
    Product
    Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy
    Lots / codes
    Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05242016A (07/08/2016).
    Distribution
    Nationwide
    Quantity
    5 vials
    Recall started
    November 17, 2016 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0280-2017

Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.

What the recall classes mean

  • Class I Most serious: use could cause serious health problems or death.
  • Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
  • Class III Not likely to cause health problems — for example a labelling or packaging fault.

Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 5, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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